Penumbra System RED 68 Reperfusion Catheter recalled for fracture risk due to manufacturing defect
Penumbra System RED 68 Reperfusion Catheters (REF: RED68KIT) may fracture during use due to a manufacturing defect. The affected lots are H00008699, H00008701, H00008702, H00008703, and C00020038. These catheters were distributed worldwide, including throughout the United States.
From the FDA notice · Read the official notice ↗
What to do
- If you use or have access to affected RED 68 catheters, stop using them immediately.
- Contact Penumbra, Inc. for instructions on device return or replacement.
- Healthcare facilities should verify lot numbers against the affected list and quarantine any matching inventory.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- N/A
- Illnesses reported
- None reported
- Manufactured in
- 6262 Patterson Pass Rd Ste A, N/A, Livermore, CA, United States
- Classification
- Class II
- Recall number
- Z-2770-2026
In the FDA's words
- Description
- Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT Due to manufacturing issues, reperfusion catheters may fractures UDI: 00815948024113/Lots: H00008699, H00008701, H00008702, H00008703, and C00020038 Distribution: Worldwide - US Nationwide distribution including in the states and territories of AK, AL, AE, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, Puerto Rico and the countries of Brazil, Canada, Colombia, Ecuador, Indonesia, Israel, Lebanon, Mexico, Mongolia, Philippines, Saudi Arabia, Thailand, and United Arab Emirates. Affected quantity: N/A
- Hazard
- Due to manufacturing issues, reperfusion catheters may fractures